Ozanimod

Find out more about ozanimod

• How does ozanimod work?
  Similar to fingolimod, ozanimod is thought to act by trapping certain immune cells (called T cells) in the body’s lymph nodes. This means the cells cannot enter the brain and spinal cord and therefore stops them from attacking and damaging myelin.
• How is ozanimod taken?
  Ozanimod is a tablet taken daily.
• Latest clinical trial results

  RADIANCE phase 3 trial

  This phase 3 trial tested if two doses of ozanimod can reduce relapses in 1,200 people with relapsing MS compared with beta interferon.

  Initial results from this trial were announced in May 2017. People taking either dose of ozanimod were reported to have a lower relapse rate than those taking weekly beta interferon therapy. The drug also reduced the number of MRI lesions and slowed the loss of brain volume compared with beta interferon. While these results still need to be published, they're an encouraging sign for ozanimod.

  SUNBEAM phase 3 trial

  Results of this phase 3 trial were announced in February 2018 but have yet to be fully published. The trial involved 1,346 people with relapsing MS who took either a high or low dose of the drug for 2.5 years.
  

  Both doses of ozanimod significantly reduced relapse rates compared with beta interferon (48% for the high dose and 33% for the low dose). Ozanimod also reduced the number of new lesions on MRI scans by 48% (high dose) and 25% (low dose) compared with placebo.

  Extension study

  Finally, Celgene will also be running an extension study. This means that every participant on the phase 3 trials can continue taking ozanimod after those trials finish for up to five years. This will be to evaluate any long-term adverse effects, and is due to finish in mid-2020.

• What are the side effects of ozanimod?

  In the phase 2 trial, three serious adverse effects (optic neuritis, unexplained pain and cellular changes to the cervix) were noted, but not proven to be related to the therapy.

  Other reactions included headaches, urinary tract infections and an initial increased heart rate.

  The safety of ozanimod will be further explored in the two phase 3 trials.

• How does ozanimod compare with current therapies?
  Ozanimod is currently being compared to beta interferon-1a (an available disease modifying therapy), but we don't have the results yet.
• When is ozanimod likely to become available?
  If the phase 3 trials are successful, Celgene may be able to present their data to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) so that the licensing process can begin. This process tends to take approximately one year.